Olopatadine hydrochloride

Manufacturer: Golden State Medical Supply, Inc. | Apotex Inc.
Effective date: 2025-11-24
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:20:45

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each tablet)

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

Purpose

Antihistamine and redness reliever

Uses

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Directions And Dosage

Directions

adults and children 2 years and older: put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: Consult a doctor

Other Label Information

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Questions?

1-800-706-5575 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Principal Display Panel

TWICE DAILY RELIEF Olopatadine HCl Ophthalmic Solution, USP 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief NDC 51407-663-05

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1111339	olopatadine HCl 0.1 % Ophthalmic Solution	PSN	4
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	4
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	4
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OLOPATADINE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20220128

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1	Product name	3	20210312
ee1438f7-d464-b7de-1b3a-aae378f7d672	Product name	8	20200121
4101b788-a943-3f81-6947-4acf7be2af4d	Product name	4	20190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3ee	Product name	1	20150323
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51407-663-05	Olopatadine hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		4
51407-663-05	Olopatadine hydrochloride	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-663-05	ML - Milliliter	51407-663	e2653a11-f708-4142-9f2a-df2efb992764	1	2022-12-07

Products#

OLOPATADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51407-663	51407-663-05

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
OLOPATADINE HYDROCHLORIDE	2XG66W44KF	ACTIM
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT

Complete SPL Sections#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

Purpose

OTC - PURPOSE SECTION

Antihistamine and redness reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Other information

SPL UNCLASSIFIED SECTION

Only for use in the eye Store between 4ºC to 25ºC (39ºF to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Questions?

OTC - QUESTIONS SECTION

1-800-706-5575 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TWICE DAILY RELIEF Olopatadine HCl Ophthalmic Solution, USP 0.1% Antihistamine and Redness Reliever Eye Allergy Itch & Redness Relief NDC 51407-663-05

Source Document#

Source XML